FDA label b896a442-db94-c6f3-e053-2a95a90a33ac

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

SPL set ID: caa6b5a4-cec3-44bf-9f13-3c3efba86b40
SPL ID: b896a442-db94-c6f3-e053-2a95a90a33ac
Version: 3
Effective date: 2021-01-10
Source export date: 2026-09-28
Source partition: 4
Source file: https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:22:51

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 2 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
spl id		b896a442-db94-c6f3-e053-2a95a90a33ac	id
spl set id		caa6b5a4-cec3-44bf-9f13-3c3efba86b40	set_id

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings: For external use only. Do not use in or on the eyes, mouth, mucous membranes or genitalia. Do not allow treated skin to contact infants, children or pets. Do not tightly bandage. Do not use with a heating pad. Do not use with topical pain-relieving medications. May result in burning sensation of the skin or skin rash. May rarely result in an increase or decrease effects of other medications, lightheadedness, drowsiness, fatigue, mood changes, hypotension (low blood pressure), dry mouth, psychomotor slowing, changes in appetite and weight. Do not drive or operate machinery if drowsy while using this medication. May rarely result in stains to clothing, bedding or furniture.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.